Drospirenone / Estradiol Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 2, 2024.

Applies to drospirenone / estradiol: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits every 3 to 6 months to discuss whether you need to continue taking this medicine. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes or are overweight or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.

Using this medicine for a long period of time may increase your risk of endometrial cancer, breast cancer, or uterine cancer. Talk with your doctor about this risk. Do not use this medicine if you have had your uterus (womb) removed (hysterectomy). Check with your doctor immediately if your experience abnormal vaginal bleeding.

Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Tell your doctor or dentist who treats you knows that you are using this medicine before any kind of surgery (eg, surgery that will require inactivity for a long time) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also affect the results of certain medical tests.

Check with your doctor immediately if severe headache, sudden loss of vision, or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

While you are taking this medicine be careful to limit the amount of alcohol that you drink.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects

Along with its needed effects, drospirenone/estradiol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking drospirenone / estradiol:

Other side effects

Some side effects of drospirenone / estradiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to drospirenone / estradiol: oral tablet.

General adverse events

The most common adverse events were gastrointestinal and abdominal pain, female genital bleeding, breast pain, and headache.^[Ref]

Genitourinary

• Very common (10% or more): Breast pain or discomfort (17.9%), female genital tract bleeding (14%)
• Common (1% to 10%): Breast enlargement, uterine fibroids enlarged, menstrual disorder, vaginal discharge, leukorrhea, vulvovaginal fungal infections,cervical polyp
• Uncommon (0.1% to 1%): Urinary tract disorder, urinary tract infection, endometrial hyperplasia, fibrocystic breast, uterine disorder, ovarian disorder, cervix disorder, pelvic pain, vulvovaginal disorder, vaginal candidiasis, vaginitis, vulvovaginitis, dysmenorrhea, ovarian cyst, vaginal dryness
• Rare (less than 0.1%): Salpingitis, galactorrhea^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, gastrointestinal and abdominal pain, diarrhea, abdomen enlarged, abdominal bloating
• Uncommon (0.1% to 1%): Gastrointestinal disorder, constipation, vomiting, dry mouth, flatulence, taste disturbance^[Ref]

Nervous system

• Common (1% to 10%): Migraine, headache
• Uncommon (0.1% to 1%): Dizziness, paresthesia, concentration ability impaired, vertigo^[Ref]

Psychiatric

• Common (1% to 10%): Depression, nervousness, emotional lability, mood swings

Uncommon (0.1% to 1%): Libido decreased, anxiety, sleep disorder^[Ref]

Other

• Common (1% to 10%): Peripheral edema, asthenia, localized edema, hot flushes
• Uncommon (0.1% to 1%): Weight gain, weight loss, generalized edema, chest pain, malaise, chills, laboratory test abnormal, taste disturbance
• Rare (less than 0.1%): Tinnitus^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Palpitation, hypertension, thrombophlebitis, varicose vein, venous thrombosis, superficial thrombophlebitis, vasodilation
• Rare (less than 0.1%): Venous and arterial thromboembolic events
• Frequency not reported: Cardiac failure, atrial flutter, QT interval prolonged, cardiomegaly^[Ref]

Venous and arterial thromboembolic events include peripheral deep vein occlusion, thrombosis and embolism/pulmonary vascular occlusion, thrombosis, embolism, infarction, myocardial infarction, cerebral infarction, and stroke not specified as hemorrhagic.^[Ref]

Oncologic

• Common (1% to 10%): Benign breast neoplasm, benign neoplasm of cervix uteri
• Uncommon (0.1% to 1%): Breast carcinoma, benign uterine neoplasm
• Postmarketing reports: Breast cancer^[Ref]

Musculoskeletal

• Common (1% to 10%): Pain in extremity
• Uncommon (0.1% to 1%): Back pain, pain in pelvis, arthralgia, muscle cramps
• Rare (less than 0.1%): Myalgia^[Ref]

Respiratory

• Uncommon (0.1% to 1%): Dyspnea^[Ref]

Hypersensitivity

• Postmarketing reports: Hypersensitivity reactions (including rash, pruritus, and urticaria)^[Ref]

Dermatologic

• Uncommon (0.1% to 1%): Skin disorder, acne, alopecia, pruritus, rash, hirsutism, hair disorder, sweating increased^[Ref]

Ocular

• Uncommon (0.1% to 1%): Eye disorder, visual disturbance^[Ref]

Metabolic

• Rare (less than 0.1%): Increased appetite, anorexia, hyperlipidemia,
• Frequency not reported: Hyperkalemia^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Liver function test abnormal^[Ref]

Hematologic

• Rare (less than 0.1%): Anemia^[Ref]

Endocrine

• Frequency not reported: Blood aldosterone increased^[Ref]

See also:

Further information

Drospirenone/estradiol side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer